RECRUITING

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Description

The goal of this research is to learn how a new device called the wireless thermal capsule (WTC) can collect thermal data to help see diseases that happen in the gastrointestinal (GI) tract, such as Crohn's Disease.

Study Overview

Study Details

Study overview

The goal of this research is to learn how a new device called the wireless thermal capsule (WTC) can collect thermal data to help see diseases that happen in the gastrointestinal (GI) tract, such as Crohn's Disease.

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Condition
Crohn Disease
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject is 18 -75 years old
  • * Subject is considered healthy, with no known illnesses
  • * Subject can follow fasting requirements
  • * Subject can follow bowel prep instructions
  • * Subject can provide informed consent
  • * Subject is older than 75 years of age
  • * Subject with current dysphagia or any swallowing disorder
  • * Subject with any current condition believed to have an increased risk of capsule retention such as gastrointestinal strictures, intestinal tumors, bowel obstruction, incomplete colonoscopies or fistula
  • * Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility
  • * Subject with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding
  • * Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months
  • * Subject with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • * Subjects with a known contradiction to metoclopramide
  • * Subjects with a known contraindication to polyethylene glycol
  • * Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia
  • * Subject who has had intestinal surgery in the past
  • * Subject with a history of congestive heart failure
  • * Subject with Type I or Type II Diabetes
  • * Subject has a cardiac pacemaker or other implanted electromedical device.
  • * Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • * Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study
  • * Subject with delayed gastric emptying
  • * Subject who is pregnant, suspected pregnant, or is actively breast-feeding.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Massachusetts General Hospital,

Guillermo Tearney, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-04-30